National Institutes of Health-sponsored trial enrolls patients at Magee-Womens Hospital

September 17, 2003

PITTSBURGH, Sept. 16 - Researchers at the Magee-Womens Research Institute and Magee-Womens Hospital of the University of Pittsburgh Medical Center (UPMC) are seeking volunteers for a study to treat infertility in women with polycystic ovary syndrome (PCOS).

Magee is one of a dozen institutions participating in this multi-center trial, which is being funded by the National Institute of Child Health and Human Development, a division of the National Institutes of Health.

The study is the largest of its kind ever conducted to compare the effectiveness of drugs used to treat infertility to that of metformin, a drug typically used to treat type 2 diabetes. Magee-Womens seeks to enroll 60 women with infertility due to PCOS who are trying to become pregnant. Counting all centers, the study will enroll 678 women over three years.

"We want to discover which treatment options are best for first-line treatment of PCOS-related infertility," said Gabriella Gosman, M.D., assistant professor of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh School of Medicine and principal investigator for the local study.

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"This is the first trial designed to answer the question in such a rigorous way."

The study will compare the effectiveness of the fertility drug clomiphene citrate, commonly known as clomid, the diabetes drug metformin and a combination of clomid and metformin.

In polycystic ovary syndrome, an excess of male hormones interferes with normal ovulation and other metabolic systems. Ovarian cysts form and enlarge the ovaries. In addition to infertility, PCOS symptoms can include irregular menstrual periods, excessive body and facial hair, acne and obesity, with weight concentrated around the abdomen.

"Women with PCOS rarely ovulate or not at all," said Dr. Gosman. "Many require medical help to get pregnant."

Five to 10 percent of women of reproductive age have PCOS. The syndrome begins in childhood, but is often undiagnosed until adulthood, when women fail to become pregnant.

"We see a lot of women with PCOS-related infertility," Dr. Gosman continued, estimating the number at 450 over the past three years.

Perhaps of paramount importance, the study aims to provide a better understanding of PCOS, which can have lifelong consequences, she said. Women with untreated PCOS are at increased risk for diabetes, heart disease, high blood pressure and cancer of the uterine lining, or endometrium. Current treatments include the use of oral contraceptives to regulate menstruation and weight-loss programs to address obesity.

Infertility is the symptom that most often sends women with PCOS to their doctors, yet it has been difficult to treat successfully, said Dr. Gosman.

Participants in the study will be divided into three groups and randomly assigned to receive clomid, metformin or a combination of both drugs. Those receiving a single drug will also get a placebo so that neither the women nor the researchers will know who is receiving which medications until the study is completed.

The diabetes drug metformin has shown promise in other clinical trials aimed at PCOS-related infertility because of the way the drug works on the body, said Dr. Gosman. Women with PCOS produce too much insulin. Metformin lowers levels of insulin and male hormones. These effects, doctors believe, often help women to ovulate spontaneously.

"The problem is that any single drug we use on women with PCOS tends to have limited effects," said Dr. Gosman. "So our theory is that, to help women get pregnant, it may be best to stimulate the ovaries and to lower insulin levels."

Since the study began nationwide in 2002, 179 women have enrolled. Magee began enrolling patients a few weeks ago, Dr. Gosman said.

Women wishing to take part in the study should be between the ages of 18 and 39 and trying to conceive.

In addition, participants should have eight or fewer periods a year, or have periods that are 45 or more days apart, and have elevated levels of testosterone.

Volunteers can expect to participate in the study between 30 and 32 weeks and to be monitored for possible side effects and for pregnancy while taking the medication. Participants will receive all study medications free of charge, in addition to a physical examination including ultrasound of the ovaries, a pregnancy test and a confirmatory ultrasound test once pregnancy is achieved.

For more information or to enroll, call Kathleen Laychak, study coordinator, at (412) 641-1483.

Magee-Womens Research Institute, the country's first research institute devoted to women and infants, was formed in 1992 by Magee-Womens Hospital of UPMC. The University of Pittsburgh School of Medicine's department of obstetrics, gynecology and reproductive sciences is one of the top three funded NIH departments in the nation.